A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine

Human papillomavirus (HPV) infection can cause genital warts and cervical cancer. HPV types 6 and 11 cause >90% of genital wart cases; HPV16 and 18 cause 70% of cervical cancers. A prophylactic HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine may substantially reduce the incidence o...

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Bibliographic Details
Published in:Vaccine 2004-08, Vol.22 (23), p.3004-3007
Main Authors: Ault, Kevin A, Giuliano, Anna R, Edwards, Robert P, Tamms, Gretchen, Kim, Lee-Lian, Smith, Judith F, Jansen, Kathrin U, Allende, Maria, Taddeo, Frank J, Skulsky, DeeMarie, Barr, Eliav
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies, Viral - analysis
Antibodies, Viral - biosynthesis
Applied microbiology
Binding sites
Biological and medical sciences
Cervical cancer
Double-Blind Method
Female
Fundamental and applied biological sciences. Psychology
Human papilloma virus
Human papillomavirus
Human papillomavirus 16
Human papillomavirus 18
Humans
Infections
Medical sciences
Microbiology
Miscellaneous
Papillomaviridae - immunology
Papillomavirus Infections - immunology
Papillomavirus Infections - prevention & control
Papillomavirus Vaccines
Serology
Studies
Time Factors
Tumors
Vaccination
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Viral Vaccines - adverse effects
Viral Vaccines - immunology
Viral Vaccines - therapeutic use
Virology
Womens health
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Summary:Human papillomavirus (HPV) infection can cause genital warts and cervical cancer. HPV types 6 and 11 cause >90% of genital wart cases; HPV16 and 18 cause 70% of cervical cancers. A prophylactic HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine may substantially reduce the incidence of these lesions. This report describes the results of a phase I study of the HPV18 component of such a vaccine. Forty women were randomized to receive either HPV18 L1 VLP vaccine or placebo. Anti-HPV18 responses were measured using a competitive radioimmunoassay (cRIA). Tolerability was evaluated using vaccination report cards (VRC). The study showed that the HPV18 L1 VLP vaccine was generally well-tolerated and highly immunogenic. Peak anti-HPV18 geometric mean titers (GMT) in vaccines were 60-fold greater than those observed in women following natural HPV18 infection. Further studies of a multivalent HPV L1 VLP vaccines are warranted.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2004.02.020